(73 days)
No
The device description details a spectrophotometric chemical reaction and measurement process. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as "For in vitro diagnostic use only" and measures total iron-binding capacity in human serum to aid in the diagnosis of various conditions. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" multiple times and details how the measurement of total iron-binding capacity (TIBC) is useful "in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning." This directly indicates its use in diagnosing medical conditions.
No
The device description clearly details physical reagents (liquid and lyophilized), calibrators, and performance verifiers, which are all hardware components. It also mentions a clinical chemistry instrument (VITROS 5,1 FS Chemistry System) which is a hardware system. The 510(k) is for these physical products, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." This is the most direct indicator.
- Measurement of Biomarkers: The device is used to "quantitatively measure total iron-binding capacity (TIBC) in human serum." Measuring biomarkers in biological samples is a core function of IVDs.
- Clinical Application: The intended use mentions the usefulness of TIBC measurement in the "differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning." This indicates a clinical purpose for the test results.
- Components: The description details reagents, calibrators, and controls, which are typical components of an IVD system used for laboratory testing.
- Predicate Devices: The listed predicate devices are also IVD products (reagents, calibrators, and performance verifiers).
All of these factors strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.
Product codes
JMO, JIS, JJY
Device Description
The VITROS Chemistry Products dTIBC Reagent is a dual chambered package containing ready-to-use liquid reagents. Reagent 1, an acidic buffer containing ferric ions bound to chromazurol B (iron-binding dye) is added to the sample. The acidic pH releases iron from transferrin and the released iron binds to the excess chromazurol B. Reagent 2, a neutral buffer is added, shifting the pH, which results in increased affinity of transferrin for iron. Serum transferrin rapidly extracts iron from the dye-iron complex. The decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the sample and is measured spectrophotometrically at 660 nm. Once a calibration has been performed, the TIBC concentration in each unknown sample can be determined using the I TDO collection curve and the measured absorbance obtained in the assay of the sample. The VITROS Chemistry Products Calibrator Kit 29 is a two level standard used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron binding capacity (TIBC). VITROS Calibrator Kit 29 level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. VITROS Calibrator Kit 29 level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals. The VITROS Chemistry Products FS Reconstitution Diluent is processed water used to reconstitute the VITROS Calibrator Kit 29 level 2. The VITROS Chemistry Products Performance Verifiers I and II are lyophilized materials prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The lyophilate is reconstituted using diluent manufactured from processed water to which inorganic salts have been added. These are assayed quality control materials are used to monitor the performance of the VITROS dTIBC assay on the VITROS 5,1 FS System.
The VITROS dTIBC assay utilizes VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline), a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 (Saline) is prepared from processed water to which inorganic salt has been added. Diluent 2 (BSA) is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS dTIBC assay.
Equivalence to predicates was demonstrated using commercially available reagents along with patient samples. The relationship between the VITROS dTIBC assay and the predicate device, determined by least squares linear regression, is: VITROS dTIBC = 0.94 X + 12.99 (μg/dL), with a correlation coefficient of 0.981, where X is the Dade Behring Total Iron Binding Capacity (IBCT) Flex assay on the Dimension® clinical chemistry system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient: 0.981
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
inical Diagnostics
DEC 2 3 2005
Columon Johnon company 100 Indigo Creek Drive
Rochester, New York 14626-5101
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, New York 14626-5101
(585) 453-4253
Contact Person: Darlene Phillips |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | October 10, 2005 |
| Device name | Trade or Proprietary Names:
VITROS Chemistry Products dTIBC Reagent
VITROS Chemistry Products Calibrator Kit 29
VITROS Chemistry Products Performance Verifiers I & II |
| | Common Names:
Total iron binding capacity assay |
| | Classification Names:
Iron-binding capacity test system (862.1415): Class: I |
| | Calibrator (862.1150): Calibrator Kit 29: Class II. |
| | Quality Control material (assayed and unassayed) (862.1660): Class I (general controls). Since these devices (VITROS Performance Verifiers I & II) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act. |
1
The VITROS Chemistry Products dTIBC assay is substantially equivalent to 4. Predicate the Dade Behring Total Iron Binding Capacity (IBCT) Flex® assay on the Devices Dimension® clinical chemistry systems. The VITROS Chemistry Products Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II. The VITROS Chemistry Products dTIBC Reagent is used in conjunction with 5. Device the VITROS Chemistry Products Calibrator Kit 29 on the VITROS 5,1 FS description Chemistry Systems for the quantitative measurement of TIBC in human serum. The VITROS Chemistry Products dTIBC Reagent is a dual chambered package containing ready-to-use liquid reagents. Reagent 1, an acidic buffer containing ferric ions bound to chromazurol B (iron-binding dye) is added to the sample. The acidic pH releases iron from transferrin and the released iron binds to the excess chromazurol B. Reagent 2, a neutral buffer is added, shifting the pH, which results in increased affinity of transferrin for iron. Serum transferrin rapidly extracts iron from the dye-iron complex. The decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the sample and is measured spectrophotometrically at 660 nm. Once a calibration has been performed, the TIBC concentration in each unknown sample can be determined using the I TDO collection curve and the measured absorbance obtained in the assay of the sample. The VITROS Chemistry Products Calibrator Kit 29 is a two level standard used to calibrate VITRÓS 5,1 FS Chemistry Systems for the quantitative measurement of total iron binding capacity (TIBC). VITROS Calibrator Kit 29 level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. VITROS Calibrator Kit 29 level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals. The VITROS Chemistry Products FS Reconstitution Diluent is processed water used to reconstitute the VITROS Calibrator Kit 29 level 2. The VITROS Chemistry Products Performance Verifiers I and II are lyophilized materials prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The lypohilate is reconstituted using diluent manufactured from processed water to which inorganic salts have been added. These are assayed quality control materials are used to monitor the performance of the VITROS dTIBC assay on the VITROS 5,1 FS System.
2
- The VITROS dTIBC assay utilizes VITROS Chemistry Products FS Diluent 5. Device Pack 2 (BSA/Saline), a common reagent that is used by multiple assays on the description VITROS 5,1 FS System. This is a dual chambered package containing two (continued) ready-to-use liquid diluents. Diluent 1 (Saline) is prepared from processed water to which inorganic salt has been added. Diluent 2 (BSA) is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5, I FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924). VITROS Chemistry Products dTIBC Reagent: For in vitro diagnostic use 6. Device only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively intended measure total iron-binding capacity (TIBC) in human serum. uses VITROS Chemistry Products Calibrator Kit 29: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent. VITROS Chemistry Products Performance Verifiers I & II: For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls used to monitor the performance of VITROS Chemistry Systems. The VITROS Chemistry Products dTIBC Reagent and VITROS Chemistry 7. Comparison Products Calibrator Kit 29 are substantially equivalent to the Dade Behring to predicate Total Iron Binding Capacity (IBCT) Flex® reagent cartridge (K994115) on devices the Dimension® clinical chemistry systems. (K994115) and Dade Behring IBCT Calibrator (K994114) (predicate devices) which were cleared by the FDA for IVD use. The relationship between the VITROS dTIBC assay and the predicate device, determined by least squares linear regression, is: VITROS dTIBC = 0.94 X + 12.99 (μg/dL),
with a correlation coefficient of 0.981, where X is the Dade Behring Total Iron Binding Capacity (IBCT) Flex assay on the Dimension® clinical chemistry system.
3
- The VITROS Chemistry Products Performance Verifiers I & II are 7. Comparison substantially equivalent to the VITROS Chemistry Products Performance to predicate Verifiers I & II (predicate device) which was cleared by the FDA (K042006) devices for IVD use. (continued)
In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS dTIBC assay.
Tables 1 and 2 summarize the similarities and differences between the new devices and the predicates.
- Similarities and differences between the VITROS dTIBC assay (new device) Table 1 and the DADE IBCT assay (predicate device).
| Similarities | |
|---|---|
| Intended Use | For in vitro diagnostic use only. Used to quantitatively |
| measure total iron-binding capacity (TIBC) in human | |
| samples. The iron binding capacity is useful in the | |
| differential diagnosis of anemia, iron deficiency anemia, | |
| thalassemia, sideroblastic anemia, and iron poisoning. | |
| Sample | None required |
| Pretreatment | |
| Instrumentation | Clinical chemistry analyzer |
| Calibration | Traceable to NIST SRM 937 |
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | VITROS dTIBC assay | |
| (New device) | DADE IBCT assay | |
| (Predicate device) | ||
| Sample Type | Human Serum | Human Serum and plasma |
| Reportable Range | 60 - 650 µg/dL | 0 - 1000 µg/dL |
| Calibrators | Two levels | Three levels |
4
510(k) Summary (continued)
- Similarities and differences between the VITROS Performance Verifiers (new Table 2 device) and the VITROS Performance Verifiers (predicate device).
| Similarities | |
|---|---|
| Matrix | The lyophilized performance verifiers are prepared from |
| processed human serum to which enzymes, electrolytes, | |
| stabilizers, preservatives, and other organic analytes have | |
| been added. | |
| Diluent | Manufactured from processed water to which inorganic |
| salts have been added. | |
| Number of levels | Two |
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | VITROS Performance | |
| Verifiers | ||
| (New Device) | VITROS Performance | |
| Verifiers | ||
| (Predicate Device) | ||
| Indications for | ||
| Use | For in vitro diagnostic use | |
| only. Assayed controls used to | ||
| monitor the performance on | ||
| VITROS Chemistry Systems. | ||
| New additional intended use: | ||
| to monitor performance of | ||
| VITROS dTIBC assay on | ||
| VITROS 5,1 FS Chemistry | ||
| Systems. | For in vitro diagnostic | |
| use only. Assayed | ||
| controls used to monitor | ||
| the performance on | ||
| VITROS Chemistry | ||
| Systems. | ||
| VITROS assays | ||
| supported | VITROS dTIBC MicroTip | |
| assay in addition to all of those | ||
| supported by the predicate | ||
| device. | Several assays including. | |
| VITROS ALB, TP, | ||
| TRIG, URIC, LAC, and | ||
| dHDL, and TIBC | ||
| MicroSlide® assays and | ||
| VITROS dHDL and | ||
| dLDL MicroTip® assays. |
- The data presented in the premarket notification provide a reasonable assurance Conclusions that the VITROS dTIBC assay and the VITROS Chemistry Products Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.
Equivalence to predicates was demonstrated using commercially available reagents along with patient samples.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEC 2 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Darlene Phillips Regulatory Associate Ortho-Clinical Diagnostic, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K052867
Trade/Device Name: VITROS Chemistry Products dTIBC Regent VITROS Chemistry Products Calibrator Kit 29 VITROS Chemistry Products Chemistry Performance Verifiers I & II Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I Product Code: JMO, JIS, JJY Dated: October 7, 2005 Received: October 11, 2005
Dear Ms. Phillips:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough maing of substantial equivalence of your device to a legally prematics notification: "The results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the I ou may other before, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):__ K052867
VITROS Chemistry Products dTIBC Reagent Device Name(s): VITROS Chemistry Products Calibrator Kit 29 VITROS Chemistry Products Performance Verifiers I & II For in vitro diagnostic use only. VITROS Chemistry Indications for Use: Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ann Chockii
Division Sign-off
Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052867